Hypotheses: Rifapentine (given as water-dispersible monolayer and/or fixed dose combination
with isoniazid) dosing in HIV-infected and uninfected children ≤ 12 years of age with latent
TB infection (LTBI) or with exposure to Mycobacterium tuberculosis (M. tuberculosis) will
require higher mg/kg rifapentine dosing than adults to achieve adult- exposures which are
correlated with efficacy in trials of TB prevention. Investigators further hypothesize that
rifapentine will be safe and well-tolerated in HIV-infected and uninfected children who
require treatment for LTBI.
Phase:
Phase 1/Phase 2
Details
Lead Sponsor:
Centers for Disease Control and Prevention
Collaborators:
Chris Hani Baragwanath Academic Hospital Johns Hopkins University Sanofi University of Cape Town University of Stellenbosch Washington D.C. Veterans Affairs Medical Center